Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sevoflurane
AbbVie Limited
N01AB; N01AB08
Sevoflurane
100 percent volume/volume
Inhalation vapour, liquid
Product subject to prescription which may not be renewed (A)
Halogenated hydrocarbons; sevoflurane
Marketed
1995-04-19
PACKAGE LEAFLET: INFORMATION FOR THE USER SEVORANE 100% V/V INHALATION GAS (SEVOFLURANE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor, surgeon or anaesthetist. - If you get any side effects, talk to your doctor or anaesthetist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Sevorane is and what it is used for 2. What you need to know before receiving Sevorane 3. How Sevorane is given 4. Possible side effects 5. How to store Sevorane 6. Contents of the pack and other information 1. WHAT SEVORANE IS AND WHAT IT IS USED FOR Sevorane contains the active ingredient sevoflurane. Sevoflurane belongs to a group of medicines called anaesthetics. Sevorane is an anaesthetic that is breathed in (inhaled), and is used to induce and maintain a deep, pain- free sleep (general anaesthesia) in adults and children during an operation. If Sevorane is used in dental operations these must be performed in a hospital or day care unit. 2. WHAT YOU NEED TO KNOW BEFORE RECEIVING SEVORANE DO NOT RECEIVE SEVORANE; if you have been told previously that you should not receive general anaesthesia. if you know that you are ALLERGIC to sevoflurane or any other anaesthetics, or any of the other ingredients in Sevorane. if you or any member of your family has experienced a condition called malignant hyperthermia (rapid rise in body temperature) during an operation with Sevorane or any other anaesthetic. if you are undergoing dental procedures outside a hospital or day care unit. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR ANAESTHETIST BEFORE RECEIVING SEVORANE IF; you have any other illness not connected to your operation, such as kidney, brain or heart problems, severe headaches, feeling sick or being sick. you have liver problems. Some anaesthetics can occasionally cause probl Read the complete document
Health Products Regulatory Authority 27 February 2019 CRN008Q3T Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sevorane 100% v/v Inhalation Gas 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Sevoflurane 100% v/v For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Inhalation gas Nonflammable, volatile liquid for administration as an inhalation anesthetic. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sevoflurane is indicated for induction and maintenance of general anaesthesia in adult and paediatric patients. Use of sevoflurane in dental anaesthesia should be restricted to hospitals or day care units only (see section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Premedication should be selected according to the need of the individual patient, and at the discretion of the anaesthesiologist. SURGICAL ANAESTHESIA: Sevoflurane should be delivered via a vaporiser specifically calibrated for use with sevoflurane so that the concentration delivered can be accurately controlled. MAC (minimum alveolar concentration) values for sevoflurane decrease with age and with the addition of nitrous oxide. The table below indicates average MAC values for different age groups. TABLE 1. MAC VALUES FOR ADULTS AND PAEDIATRIC PATIENTS ACCORDING TO AGE AGE OF PATIENT (YEARS) SEVOFLURANE IN OXYGEN SEVOFLURANE IN 65% N20/35%02 0 – 1 months* 3.3% 1 - < 6 months 3.0% 6 months - < 3 years 2.8% 2.0%@ 3 - 12 2.5% 25 2.6% 1.4% 40 2.1% 1.1% 60 1.7% 0.9% 80 1.4% 0.7% *Neonates are full term gestational age. MAC in premature infants has not been determined @ In 1 - <3 year old paediatric patients, 60%N20/40%02 was used Sevoflurane is similar to Isoflurane in the sensitisation of the myocardium to the arrhythmogenic effect of exogenously administered adrenaline. INDUCTION: Dosage should be individualised and titrated to the desired effect according to the patient's age and clinical status. A short acting barbiturate or other intravenous induction agent may be administered followed by in Read the complete document